Federal health advisers narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease, a potential setback for patient groups who have lobbied for the medication’s approval.
Advisers to the Food and Drug Administration voted 6-4 that a single study from Amylyx Pharmaceuticals failed to establish the drug’s effectiveness in treating the deadly neurodegenerative disease ALS, amyotrophic lateral sclerosis.
Their vote is not binding and the FDA will make the final decision on whether to grant approval by July. The vote could be used to bolster FDA’s negative review published earlier in the week that criticized Amylyx’s mid-stage study for its small size, missing data and questionable statistical analysis.
ALS destroys nerve cells in the brain and spinal cord needed to walk, talk, swallow and — eventually — breathe. There is no cure and most people die within three to five years of their first symptoms. “Slowing down the loss of function is significant to me and to my family,” stated Becky Mourey, a former music teacher and ALS patient, in comments read by her daughter. “More time to tell my children I love them with my own voice is everything to me.”
Amylyx’s drug comes as a powder that combines two older drugs: one prescription medication for liver disorders and a dietary supplement long used in traditional Chinese medicine. In a 137-patient study in ALS patients, researchers reported those who took the drug progressed 25% more slowly than those taking a dummy drug after one year.
Österreich Neuesten Nachrichten, Österreich Schlagzeilen
Similar News:Sie können auch ähnliche Nachrichten wie diese lesen, die wir aus anderen Nachrichtenquellen gesammelt haben.
Aimee-Lou Wood announced as the face of Levi’s UK for SS22
Weiterlesen »
FDA panel narrowly sides against experimental ALS drugFederal health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease
Weiterlesen »
FDA panel narrowly sides against experimental ALS drugU.S. health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease.
Weiterlesen »
FDA skeptical of benefits from experimental ALS drugThe Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease.
Weiterlesen »
FDA Advisers Raise Doubts About Amylyx’s Experimental ALS DrugExperts advising the FDA voted that there wasn’t enough evidence to show that an experimental ALS drug from Amylyx Pharmaceuticals works, throwing approval into doubt
Weiterlesen »